FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE
K Number: K892846
·
Decision Jul 14, 1989
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
19
Applicant Total
43
Review Days
87
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Basic Information
- Device Name
- ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE
- K Number
- K892846
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.1550
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Cook Ob/Gyn
- Date Received
- April 18, 1989
- Decision Date
- July 14, 1989
- Product Code
- HIO
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HIO | Sampler, Amniotic Fluid (Amniocentesis Tray) | FDA class 1 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HIO), ordered by most recent decision date.
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RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY
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VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE
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SONO-VU US(TM), MODIFICATION
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MEGA AMNIOCENTESIS KIT
FDA 510(k)
FDA Class 1
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Other Clearances by Cook Ob/Gyn
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|---|---|---|---|
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| K030441 | SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT | Aug 29, 2003 | Substantially Equivalent |
| K023850 | SYDNEY IVF EMBRYO BIOPSY MEDIUM | Jan 22, 2003 | Substantially Equivalent |
| K013597 | TAMPONADE UTERINE BALLOON CATHETER SET | Apr 17, 2002 | Substantially Equivalent |
| K002385 | COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM, | Sep 18, 2000 | Substantially Equivalent |
| K002383 | COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT | Sep 13, 2000 | Substantially Equivalent |
| K983595 | TRANSMYOMETRIAL EMBRYO TRANSFER SET | Feb 8, 1999 | Substantially Equivalent |
| K983596 | INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING | Feb 5, 1999 | Substantially Equivalent |
| K983642 | COOK MINI-INCUBATOR | Feb 1, 1999 | Substantially Equivalent |
| K983593 | OVUM PICK-UP ASPIRATION NEEDLES | Jan 21, 1999 | Substantially Equivalent |